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Sustained Effort Network for Treatment of Status Epilepticus/European Academy of Neurology Registry on Refractory Status Epilepticus (SENSE-II/AROUSE)

The SENSE-II/AROUSE study is a European-wide effort to gather information about adult patients experiencing a serious and ongoing seizure condition called Status Epilepticus. It's not a trial testing a new treatment, but rather a way for doctors and researchers to learn from real-life patient experiences in hospitals across Belgium, Austria, Germany, the UK, and Switzerland. They are looking at things like patient characteristics, the types of treatments given, brainwave patterns (EEG), and how patients recover. By collecting this data from many patients (they aim for 3000), the study hopes to better understand this condition, find out what leads to better outcomes, and identify areas where care could be improved. This will help doctors make better decisions and design future studies.

At a glance

Status
Recruiting
Sponsor
Erasme University Hospital
Enrolment target
3,000
Start
01 Mar 2023
Estimated completion
31 Dec 2028

What is this study about?

Imagine someone having a seizure that doesn't stop or someone having many seizures very close together without fully recovering in between. This serious condition is called Status Epilepticus. The SENSE-II/AROUSE study is a big project across several European countries, including the UK, to learn more about adults who are treated for this condition.

It's not about trying out new medicines or treatments. Instead, doctors and researchers in different hospitals are carefully collecting information about their patients. They want to understand things like who gets Status Epilepticus, what kind of treatments they receive, what their brain scans (called EEGs) show, and how they recover. By looking at all this information from many patients, they hope to find patterns and figure out what helps patients get better sooner, and what might make the condition harder to treat. They're aiming to gather information from about 3,000 patients.

This information is really important because it helps medical teams understand how to provide the best care. It can also point out areas where more research is needed and guide the development of future studies that might test new treatments. They're not imposing a single treatment plan, but most participating hospitals follow similar guidelines for managing Status Epilepticus, ensuring patients receive good care while their experiences are recorded.

Key takeaways

  • Study collects information from adult patients with Status Epilepticus.
  • Aims to understand the condition, treatments, and recovery.
  • Not a trial of new medicines, but an observational study.
  • Data helps improve future care for Status Epilepticus patients.
  • No extra tests or treatments required for participation.
  • Your standard medical care remains unchanged.

Who may be eligible?

This study is looking for adults who are admitted to hospital because they are experiencing Status Epilepticus. This means you must be 18 years old or older. You could be included if Status Epilepticus is the main reason you're in hospital, or if you were admitted for something else but then developed Status Epilepticus during your stay.

However, there are a few reasons why someone might not be included. If your Status Epilepticus happened after your heart stopped (what's called post-cardiac arrest Status Epilepticus), then this study would not be the right fit for you. Also, if you are under 18 years old, you would not be able to join this particular study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Are you being treated for Status Epilepticus?
  3. Did your Status Epilepticus NOT happen after a cardiac arrest?
  4. Are you receiving care at a hospital participating in the SENSE-II/AROUSE study?
Answer every question to see your result.

What does participation involve?

As this is an observational study, you wouldn't be asked to do anything extra or receive any specific treatment just for the study. The study would simply collect information that your medical team is already gathering as part of your standard care. This includes details about your health, the treatments you receive while in hospital for Status Epilepticus, and the results of tests like brainwave recordings (EEGs). Data would be collected from the time you are admitted until you are discharged from the hospital. There are no extra visits or follow-up appointments required specifically for the study. The total duration of your participation would simply be the length of your hospital stay for Status Epilepticus.

Potential risks and benefits

There are no direct personal benefits for participating in this study, as it doesn't involve new treatments. However, the information gathered will help doctors and researchers better understand Status Epilepticus, leading to improved care for future patients. Since the study only collects information from your routine medical care, there are no additional risks associated with taking part. You also have the right to withdraw your consent at any time without affecting your medical care.

Locations (11)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Kepler University Linz
    Verified postcode
    Linz, Austria· Not yet recruiting
  • Christian Doppler Klinik of Paracelsus Medical University
    Verified postcode
    Salzburg, Austria· Not yet recruiting
  • HUB Erasme
    Verified postcode
    Brussels, Belgium· Recruiting
  • Odense University Hospital & Svenborg Hospital
    Verified postcode
    Odense, Denmark· Recruiting
  • Helsinki University Central Hospital
    Verified postcode
    Helsinki, Finland· Not yet recruiting
  • Goethe-Universität Frankfurt am Main
    Verified postcode
    Frankfurt, Germany· Not yet recruiting
  • Epilepsy Center Münster-Osnabrück, Klinikum Osnabrück
    Verified postcode
    Osnabrück, Germany· Not yet recruiting
  • Oslo University Hospital
    Verified postcode
    Oslo, Norway· Not yet recruiting
  • University Hospital Basel
    Verified postcode
    Basel, Switzerland· Not yet recruiting
  • University Hospital of Geneva
    Verified postcode
    Geneva, Switzerland· Not yet recruiting
  • Birmingham University Hospitals NHS Trust
    Verified postcode
    Birmingham, United Kingdom· Not yet recruiting

Common questions

What is Status Epilepticus?

It's a serious medical emergency where a seizure lasts for a long time or seizures happen one after another without the person fully recovering in between.

Is this study testing a new drug?

No, this study is not testing new drugs or treatments. It's observing and collecting information about current care for Status Epilepticus.

What information will the study collect?

The study will collect details about your health, treatments you receive, and brain test (EEG) results, all part of your usual medical care.

Will my privacy be protected?

Yes, all patient information is collected and stored securely, typically without your name, to protect your privacy.

Can I still receive my usual medical care if I join?

Absolutely. Joining this study will not change or affect the medical care you receive for Status Epilepticus.

How to find out more

Nicolas Gaspard, MD, PhD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Sustained Effort Network for Treatment of Status Epilepticus…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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